Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Placebo; Drug: Diane; Drug: Valette

• Registration Number: NCT00280657
• Lead Sponsor: Bayer

Brief Summary

The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Timeline

• Study Start: 2004-03-10
• Primary Completion: 2005-05-21
• Study Completion: 2005-05-21
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1326

Inclusion Criteria

• Patients with mild to moderate facial papulopustular acne

Exclusion Criteria

• Contraindication against use of hormonal contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Placebo	-
Arm 2	Diane	-
Arm 1	Valette	-

Primary Outcome Measures

Name	Time	Method
Change in lesions	6 months

Secondary Outcome Measures

Name	Time	Method
ISGA	6 months
Parameters of safety and tolerability	6 months